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EC Publishes Draft of New Mutual Recognition Regulation

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The European Commission (EC) published a Draft proposal for a new Mutual Recognition Regulation, and has launched a public consultation on the draft on December 20, 2017. The objective of the new regulation is to improve the function of mutual recognition.

By way of background, the EC published an Inception Impact Assessment on the revision of the Mutual Recognition Regulation (EC) No 764/2008 in mid-2016. One of the policy options in that document was to revise the Mutual Recognition Regulation. (See the article, EC Proposes Revisions to the Mutual Recognition Regulation for more information on the Inception Impact Assessment.)

The draft Mutual Recognition Regulation clarifies the scope of mutual recognition and facilitates the ability to demonstrate that a product is already being lawfully marketed. It proposes a voluntary Mutual Recognition Declaration “to demonstrate to the competent authorities of the Member State of destination that the goods, or goods of that type, are lawfully marketed in another Member State”.

Copies of the current proposal, along with an annex document and supporting documentation, can be assessed from the EC website. Feedback on these documents may be provided February 14, 2018, via Have your say platform (prior registration on the platform is required).